Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Although these systems promise to reduce costs and improve quality and safety, they’ve also ushered in unintended consequences as a result of human error, design flaws, and technology glitches.

Recognizing these emerging risks, CRICO—the patient safety and medical malpractice insurer for the Harvard medical community— is taking action. The Massachusetts-based company has expanded its proprietary coding system to capture EHR-related problems that have contributed to patient harm, and to guide the hospitals, physicians, and other providers it serves toward addressing vulnerabilities in their systems.

... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.

The article notes this:

... Half of the 147 cases resulted in severe injury.

Patient deaths were a likely result, too, I note.

Note that this is just one insurer's data and assuming a good number of them were local to Massachusetts, could represent a significant percentage of the annual medical malpractice lawsuits in the state (Pennsylvania, a much larger state, has about 1500 med mal lawsuits filed annually).

Note also that most cases of harm never make it to litigation due to the harsh economics of medical malpractice.

Numbers such as this will be going up as implementation, driven by HITECH incentives and penalties, accelerates in coming years. This is especially true as medical centers and physician practices with far less clinical IT expertise and savvy than Harvard's become HIT users, and as the ability to capture such events increases.

... The team asked its CRICO and Strategies members, “What vulnerabilities are you seeing? What are your risk managers worried about? What are your doctors complaining about?”

It used that feedback to draft a set of EHR-specific codes and then tested them in three datasets: CRICO (Harvard users) and two of Strategies’ larger clients, !e Doctors Company and Princeton Insurance. Based on those results, CRICO revised and approved 15 new EHR codes that went “live” in January 2013.

That means CRICO’s cadre of nurse coders can now identify EHR as a contributing factor to a malpractice claim, instead of using one of the less specific factors available in the past. [It's about time for a dose of transparency in the health IT sector - ed.] And they can flag whether the problem involved user issues, system/technology issues, or both. “In some cases,” Sato points out, “the system design sets up humans to make errors.”

This should all be no surprise to any reader of this blog. Read the whole article.

... "Despite the government’s bribe of nearly $27 billion to digitize patient records, nearly 70% of physicians say electronic health record (EHR) systems have not been worth it. It’s a sobering statistic backed by newly released data from marketing and research f rm MPI Group and Medical Economics that suggest nearly two-thirds of doctors would not purchase their current EHR system again because of poor functionality and high costs."

Here are other key findings from this national survey:

73% of the largest practices would not purchase their current EHR system. The data show that 66% of internal medicine specialists would not purchase their current system. About 60% of respondents in family medicine would also make another EHR choice.

67% of physicians dislike the functionality of their EHR systems.

Nearly half of physicians believe the cost of these systems is too high.

65% of respondents say their EHR systems result in financial losses for the practice. About 43% of internists and other specialists/subspecialists outside of primary care characterized the losses as signifcant.

About 69% of respondents said that coordination of care with hospitals has not improved.

Nearly 38% of respondents doubt their system will be viable in five years.

74% of respondents believe their vendors will be in business over the next 5 years.

My own views are:

While some might dismiss such surveys as well as reports of harms as
"anecdotes" (those same persons conflating scientific discovery with
risk management, see
http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html),
I observe that such articles/surveys are increasing in frequency the
past few years and are coming from reasonably capable observers -
clinicians - .unlike, say, a Fox News survey
of pedestrians on complex political matters.

In my opinion, organizations that have the expertise to change the current trajectory of this technology such as the American Medical Informatics Association (AMIA) needs to leave its tweed-jacket academic comfort zone and become more proactive - or perhaps I should say aggressive - in combating the industry status quo.

The health IT industry trade associations such as HIMSS have no such qualms about aggressively and shamelessly pushing their version of EHR utopia, an agenda that has led to massive profits for the industry... but to clinician survey results such as above. And to injured and dead patients.

Yesterday I spent some time in a family docs office in [redacted] who has been experiencing an EHR failure in his office. Naturally its messed up his work flow not to mention occupying hours on end of his ostensibly personal time. His reaction was mostly one of frustration.

In another situation, the ABMS is acquiring near dictatorial powers over physicians' livelihoods by essentially mandating an expensive, time consuming jumping through of hoops in the form of MOC requirements which may well evolve into MOL. Its a shakedown. Except for a few thousand members of AAPS that is seeking legal redress in Federal court, organized medicine is silent. Physicians who are undoubtedly frustrated just play the game in a grim resignation.

Where is the moral outrage? Where is the righteous anger? Another physician, a close friend of mine, feels exactly the same way. This healthcare system is poisoning our souls and is engaged in a full frontal assault against our ability to ply our trade (which we have invested so dearly in) as critical, free thinking human beings.

Extortion at its best. More ominously, we are being extinguished, not transformed, as a profession. Remolded into subservient "providers". With little blow back. Can you even imagine any other profession allowing this to happen? Try bending a lawyer over a barrel. We are exploited blue collar workers without union representation. We are essentially working in a meatpacking plant that Sinclair Lewis wrote of.

I am so tired and ashamed of being associated with a gutless group of people who call themselves physicians. I just had to get it off my chest.

If people remain indifferent to having their physicians bureaucratically overburdened and demoralized, the outcome will not be pretty in times of medical extremis.

Monday, February 24, 2014

We just discussed how the new CEO of the National Quality Forum was revealed to be a member of the board of directors of Premier Inc, and discussed the implications of this apparently intense conflict of interest.

Now another new leader of an influential non-profit organization dedicated to improving health and health care has also been shown to have major conflicts of interest.

All Hail the New President of the Institute of Medicine

In 2010, we posted about a student protest of the salaries of some top administrators at Duke University, including then Chancellor of Health Affairs Dr Victor Dzau, at a time when the university was undergoing financial difficulties. We pointed out that Dr Dzau's income was further increased by compensation received as a member of the boards of directors of multiple corporations, and further that serving as a highly paid steward of health care companies like Alnylam Pharmaceuticals, Genzyme, and Medtronic appeared to be a major conflict of interest. .

Last week Dr Victor Dzau was hailed as the new president of the Institute of Medicine. The simple version, in Modern Healthcare:

Duke
University Health System President and CEO Dr. Victor Dzau was named
president of the Institute of Medicine, succeeding the longtime
president, Dr Harvey Fineberg, the National Academy of Sciences
announced Wednesday.

Dzau, whose six-year term will begin July 1, has done research
in the area of treatment for high blood pressure and congestive heart
failure and pioneered the use of gene therapy for vascular disease, the
institute said in announcing the selection. Dzau served on the IOM
Council from 2008 through 2013, Fineberg said in a statement.

'As a physician-scientist and leader in academic medicine, Victor has
consistently demonstrated inspirational leadership, innovative thinking
and multifaceted achievement. Now, all of us at the IOM, both members
and staff, will benefit more fully from his leadership,' said Fineberg,
who has served as president of the institute for 12 years.

However, Forbes blogger Larry Husten, was the first to publicly report these memberships, drawing on our 2010 post on Dr Dzau's conflicts of interest as Duke Chancellor for Health
Affairs.

Then a blog post on Modern Healthcare by Steven Ross Johnson added some more detail,

IOM spokeswoman Jennifer Walsh said in an e-mail that Dzau initiated
steps to resign from his corporate board positions before Wednesday's
announcement and that he has committed to severing the ties by the time
he begins his six-year term in July.

It did not mention why the IOM press release and the initial news stories did not mention Dr Dzau's board memberships nor his intention to resign from them. The IOM spokeswoman apparently did not discuss why Dr Dzau was going to resign his board memberships now, while he had maintained them as a member of the IOM Council from 2008 to 2013.

Since then, later on 21 February, a single mainstream media article, in Bloomberg, did address Dr Dzau's new job, his corporate board memberships, and his planned resignations, with emphasis on his break from PepsiCo:

The newly appointed president of the Institute of Medicine,
which advises government leaders and policymakers on health issues,
plans to resign from several corporate boards in advance of taking his
new job—including one that might have created a sticky situation.

Among the companies that Victor Dzau will sever ties with is PepsiCo (PEP),
according to Jennifer Walsh, a spokeswoman for the IOM. 'Dr. Dzau had
already decided to step down from corporate boards before he accepted
the position,' she says.

For Dzau, who’s leaving his position as
chief executive officer of the Duke University Health System to head up
the IOM, the PepsiCo relationship might have been a problem: Several of
the company’s products are among those blamed for contributing to the
obesity epidemic in the U.S. The Purchase (N.Y.)-based company is best
known for its Pepsi soft-drink line and snacks including Fritos and
Cheetos.

The IOM, which has identified solving the nation’s weight
problem as a top priority, endorsed the idea of a soda tax in a report
detailing the 'staggering toll' of obesity. The agency estimates
obesity-related illness in the U.S. costs $190 billion a year.

The Bloomberg article mentioned his memberships on the Alnylam and Medtronic boards mainly in passing.

The Rewards of Board Membership

The Modern Healthcare blog post provided a list of recent compensation Dr Dzau received from his board memberships.

According to Pepsico's 2013 proxy statement, Dzau deferred his retainer
of $66,667for the year ending Dec. 29, 2012, in lieu of 944 units of
phantom stock, where cash is paid at a future date in an amount equal to
the market value of stock shares. Dzau also serves on the boards of Alynylam Pharmaceuticals (he was paid $50,000 and received option awards of $89,000 in 2013) and medical devicemaker Medtronic (PDF) (he was paid $80,000 and received stock awards worth $140,000in 2013).

It did not mention whether he currently owns any stock, or the equivalent, in any of these companies.

However, the most recent Alnylam, Medtronic, and PepsiCo proxy statements show Dr Dzau's considerable stock holdings in these companies.

- According to the 2013 Alnylam Pharmaceuticals proxy statement, he currently owns the equivalent of 90,000 shares today worth $8,070,300 at the current price of $89.67.
- According to the 2013 Medtronic proxy statement,
he currently owns 9636 stock options and 15,200 deferred stock units
for total holdings of 25,156 share equivalents today worth $1,450,495
at a current price of $57.66.
- According to the 2013 Pepsico proxy statement,
Dr Dzau currently owns the equivalent of 36,173 shares of Pepsico
stock. today worth $2,830,537 given a current price of $78.25.

The Bloomberg article provided a somewhat lower estimate of the value his PepsiCo stock holdings based on an otherwise unidentified 2 December, 2013 filing with the US Securities and Exchange Commission. It estimated the value of his deferred stock units in Medtronic based on an April, 2013 disclosure, but did not list the stock options which appeared in the July, 2013 proxy statement. It noted his membership on the Alnylam board but did not mention that he held any shares or the equivalent in Alnylam stock.

I cannot find anything public about what, if anything, Dr Dzau plans to do with these not inconsiderable stock holdings in health care and health related corporations.

Note that as we posted in 2010, in its last proxy statement before it was acquired by Sanofi, Genzyme declared that Dr Dzau owned the equivalent of 75,137shares as of 2009, which in 2010 were worth approximately $5.3 million. I cannot tell what Dr Dzau did with these stock holdings after the merger.

Thus while there may be some confusion about this current holdings and their exact value, it seems clear that Dr Dzau has become a
multimillionaire by virtue of his holdings of stock or equivalent from
the three companies, a drug company, and medical device company, and a company whose products have apparent public health implications, on whose boards he currently sits, and possibly by virtue of his holdings in another drug/ biotechnology company on whose board he previously sat. .

The Intensity of the Conflicts

The
acuity of the conflicts presented were the President of the IOM to continue sitting on
these boards was emphasized by this description of the influence wielded
by the IOM written in an article in the Durham (NC) Herald-Sun,

Under the congressional charter of the National Academy of Sciences, the
Institute of Medicine is recognized as a primary source for
independent, scientifically informed analysis and recommendations on
health issues.

Even though Dr Dzau will apparently exit his board memberships before he becomes IOM President, the IOM has been providing such analysis
and recommendations under the supervision of a Council member who had fiduciary duties to the stockholders of two pharmaceutical
companies a medical device company, and company that makes sugar-laden
soft drinks and snack foods. It will continue to provide such analysis and recommendations under the supervision of a President who became a multimillionaire by
virtue of the stock holdings he acquired through
his board positions.

In 2006 we first discussed
a newly discovered species of conflict of interest in health care, in
which leaders of medical or health care organizations were
simultaneously serving on boards of directors of health care
corporations. We posited these conflicts would be particularly
important because being
on the board of directors entails not just a financial incentive. It
ostensibly requires board members to "demonstrate unyielding loyalty to
the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance,
3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Of
course, after the global financial collapse of 2008 made us sadder and a
little wiser, we realized that many board members actually seem to have
unyielding loyalty to their cronies among top management. However, in
any case, the stated or actual interests of a member of the board of a
health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of an
academic medical institution or a non-profit ostensibly dedicated to
improving health care quality.

Also, this case could be aggregated with that of Dr Cassel, the new CEO of the National Quality Forum (and former CEO of the American Board of Internal Medicine) who was found to be a member of the board of directors of Premier Inc, a for-profit hospital group purchasing organization.(see this post). In my humble opinion, the issue here goes even beyond blatant conflicts of interest. That top stewards of big
for-profit health care corporations could simultaneously be top
leaders of influential non-profit organizations ostensibly dedicated to improving health and health care suggests that increasingly US health care is run by an
insular group of insiders whose influence gets ever larger because of
their collective power, not necessarily because of their dedication or
ability to improvement of health care. As reported by ProPublica about Dr Cassel's case,

Rosemary Gibson,
an author and senior adviser to The Hastings Center, a research group dedicated
to bioethics in the public interest, said she wasn’t surprised at Cassel’s
outside compensation. So much money permeates decision-making in Washington,
she said, that participants have become oblivious.

'The insiders
don’t see it,' Gibson said. 'It’s like a fish in water.'

How
Would Dr Dzau Respond to Criticisms of the Companies He Directs, and How
Would His Responses Reflect on the IOM?

Even if
Dr Dzau were to resign from all three corporate boards, and sells all his
stock holdings in the three companies, as previous board member he was
responsible for the stewardship of these four companies for years.
Therefore it would not be unfair for someone to ask him to address any questionable actions of those companies that
affected patients' and the public's health.

For example, as we have
discussed here,
Medtronic has been involved in a series of recent misadventures,
including most recently a settlement between multiple hospitals and the
Us Department of Justice of charges that they allowed themselves to be
persuaded by executives of Medtronic subsidiary Kyphon to inflate their
billings for patients who had a Kyphon device implanted (look here), and a Senate report that Medtronic manipulated articles in the medical literature to market another of its products (look here).

But the awkward fact is that Dr Dzau, as a board member of Medtronic, can be seen to be a steward of that corporation, and hence responsible
for the its overall direction. Even if he were no longer a board member, he cannot erase his responsibility for Medtronic activities that occurred on his watch. Thus, Dr Dzau could easily find
herself in the uncomfortable situation of having to defend and justify
questionable past behavior by Medtronic while simultaneously wearing the
hat of President of the IOM. How that would play out is not obvious.

Summary

To date, the case of Dr Dzau as incoming president of the IOM and current board member of Alnylam Pharmaceuticals, Medtronic and Pepsico has received little attention, and therefore no ethics expert has gotten a chance to speak up in public about it, as they have about the case of Dr Cassel, the NQF, and Premier Inc. So I will have to step in.

As I have said before, Dr Joe Collier said, "people who have conflicts of interest often find
giving clear advice (or opinions) particularly difficult." [Collier J.
The price of independence. Br Med J 2006; 332: 1447-9. Link here.]
To reduce further unclear thinking and its consequences, we again urge
that academic medical institutions, and non-profit organizations
dedicated to improving patient care and public health forthwith begin
real reductions of conflicts of interest affecting all those who make
clinical or policy decisions.

The IOM ought to consider
- Immediately disclosing conflicts of interest affecting all its members, staff, and leadership in a very clear and accessible manner
- Beginning a gradual but complete phase out of such conflicts

Otherwise, we all ought to be concerned that the leadership of medicine and health care is increasingly in the hands of a small group of insiders, interchangeable executives who simultaneously or sequentially lead multiple organizations, and are likely to become more comfortable with the fellow members of this interlocking leadership than with ordinary health care professionals, patients and the public.

Potentially deadly EHR startup "issues" can number in the many thousands (as at this link);

If you don't want to subject yourself to these delays and/or glitches, you are free to select another hospital for your care.

(If you are injured or die as a result of the "Delays", then ... we're Extra-Special With Sugar On Top Sorry?)

In other words, this glib, nonchalant signage is incomplete, and misleading on its face.

While I understand its purpose, it ignores patient rights to informed
consent and knowledge of a potentially unsafe environment for care, which hospitals have to prevent as an ethical and legal obligation.

Of course, "please feel free to ask your caregiver if you have any questions" ... who may in fact be limited by contract or edict to only use "Words That Work" to further soothe unsuspecting patients (as at this link).

Friday, February 21, 2014

The story of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case refuses to go away, even if it still has not created any echoes in the mainstream media or the medical and health care literature. Now it appears that the NQF has an even bigger conflict of interest problem than previously reported.

Background

As of our last post on 5 February, 2014, the background was-
- The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
- The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
- The Department of Justice news release
also alleged that payments were made to a corporation called Health
Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
- The implication was that Dr Denham was supposed to influence a
standard writing committee run by the National Quality Forum, a well
known organization that promotes quality improvement, issues
authoritative practice standards, a form of clinical practice
guidelines, and has contracts with the US government for quality of care
activities
- The draft of the standard to prevent surgical site infection written by the committee allegedly included
the use of ChloraPrep, although mention of that specific medication was
removed in a revision
- The Department of Justice alleged that the standard was based on a
journal article sponsored by Cardinal Health, from which CareFusion
split, and which may have been manipulated by its sponsor
- NQF leaders asserted that after hearing of the case from the DOJ, the
organization severed ties with Dr Denham and the non-profit
organization he runs, established a policy not to accept money from
funding organizations whose leaders are on its committees, reviewed all
the standards set by the committee of which Dr Denham was co-chair, and
twice revised its conflict of interest policy.
- Despite these efforts by the NQF to remove excess influence by Dr
Denham, a specific recommendation to use ChloraPrep, specified by
formula but not by name, did appear in another NQF standard, one for
preventing central line infections; the NQF logo apparently appeared on
at least one educational event run by Dr Denham that advocated the use
of ChloraPrep; and CareFusion cited NQF support in at least one
promotional brochure
- In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.
- Senator Charles Grassley is now investigating

The Conflicts of the NQF CEO

In our first post about the case, I noted that at the time that Dr Denham was a committee member, the NQF seemed to have a relatively weak policy on conflicts of interest, although this post noted it was later strengthened somewhat. I also commented that the organization seemed accommodating of conflicts of interest affecting its board of directors, and to have institutional conflicts of interest in that it accepted funding from health care corporations which might have interests in NQF quality standards being written in their favor.

So maybe it should not be too great a surprise that the latest twist in this case is the revelation that the new CEO of NQF has her own quite significant conflicts of interest. Last week, ProPublica published a story about the conflicts of interest of the new CEO of the NQF. The basics were:

The top
executive at the country’s pre-eminent health care quality organization is
being paid hundreds of thousands of dollars by two large medical companies that
have a stake in the group’s work.

The payments to
Dr. Christine Cassel raise new conflict-of-interest concerns at the National
Quality Forum, which endorses benchmarks that Medicare uses to compensate
hospitals based on performance.

As ProPublica
recently reported, the Quality Forum is reviewing its conflict-of-interest
policies after being stung by allegations that the former co-chair of one of its
endorsement committees had accepted kickbacks to help a drugmaker win favorable
treatment.

Cassel received
about $235,000 in compensation and stock last year as a board
member for Premier Inc., a North Carolina company that says it provides group
purchasing and performance improvement consulting for an alliance
of 2,900 hospitals and thousands of nursing facilities and other providers.

Cassel also was
paid $189,000 as a board member for the Kaiser Foundation Health Plans and
Hospitals in 2012, Quality Forum officials confirmed to ProPublica. Kaiser’s
tax forms are not available for 2013, but they show
that in 2010 and 2011 Cassel received a total of $357,125.

Cassel, who
declined to be interviewed, took over as chief executive officer last summer
after a decade as president and CEO of the American Board of Internal Medicine.

Not unexpectedly, the official position of the NQF was nothing to see here, just move along.

The
group's chairwoman, Helen Darling, said in an email that the board was 'fully aware' of Cassel’s outside compensation when she was hired in December
2012. Darling, president of the National Business Group on Health, initially
agreed to an interview but did not respond to follow-up contacts.

Spokeswoman Ann
Greiner said the board got a legal opinion and discussed it in depth before
agreeing that Cassel could recuse herself 'where her outside board service
would be construed as an actual or perceived conflict of interest.' So far that
hasn’t happened, Greiner said.

Note that those defending NQF saw no reason to explain why it had not previously disclosed Dr Cassel's other positions or how the conflicts would be managed. Perhaps a board that includes executives of large health corporations, of a financial firm
with large health care interests, and of a trade associations for large health
care corporations would not see a problem with having a CEO who is simultaneously on the boards of a for-profit hospital group purchasing organization and a very large, albeit non-profit health care system.

Others were much more skeptical and critical.

Two ethics
experts interviewed by ProPublica said Cassel’s relationships with Kaiser and
Premier present obvious conflicts given the Quality Forum’s broad involvement in health care.

The Quality
Forum maintains a clearinghouse of more than 700 quality measures —
covering everything from tracking hospital readmissions to setting information
technology standards — that are established by expert committees and
widely adopted by U.S. hospitals and other providers.

The ethics experts
said they were uncertain how Cassel could recuse herself
to anything related to Kaiser and Premier and still do her job.

'Would that mean
every time somebody said the word ‘hospital’ she would have to say, ‘I can’t be
in this conversation?’' said Eric
Campbell, a Harvard School of Medicine professor who has published
extensively on conflicts of interest.

'Conflict of
interest is as much an appearance as it is an effect,' added Sheldon Krimsky, a medical
ethics expert at Tufts University. He called Cassel’s conflicts 'absolutely
egregious'

Campbell and
Krimsky said the cleanest way to eliminate potential conflicts would be for
Cassel to resign from the outside boards.

The plot thickens because of the amount of influence wielded by the NQF,

Having some leverage on that influence would seem to be particularly important to Premier Inc, the now publicly held for-profit group purchasing organization on whose board Dr Cassel sits,

Premier reported
revenues of $869 million in the fiscal year ending last June. It spent more
than $1 million on lobbying in 2013, according to OpenSecrets.org. In August
and November, the company urged members of Congress to instruct Medicare to run
any quality measures through the Quality Forum.

The company’s
business involves group purchasing and a consulting arm that uses data analysis
to help providers perform better on various quality metrics. In October, a
measure sponsored by Premier to track hospital care by the average length of
stay was
up for renewal by the Quality Forum.

Of course, a Premier Inc spokesperson denied that could be a problem,

[Spokesperson Blair] Childs said
Cassel’s role on the Premier board doesn’t pose any conflict of interest, and
that her relationship with Premier was vetted carefully by
the Quality Forum’s board. Cassel was a good addition to the Premier
board because of her commitment to improved care and lower costs, he said.

However, I submit that the conflict here is particularly acute because Dr Cassel is not merely a part time consultant or adviser to Premier Inc. She is on the board of directors. In 2006 we first discussed a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations. We posited these conflicts would be particularly important because being
on the board of directors entails not just a financial incentive. It
ostensibly requires board members to "demonstrate unyielding loyalty to
the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management. However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a for-profit hospital purchasing organization, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.

However, in my humble opinion, the issue here goes even beyond a blatant and undisclosed conflict of interest. That a top steward of a big for-profit health care corporation could simultaneously be the top leader of an influential non-profit health care quality improvement organization suggests that increasingly US health care is run by an insular group of insiders whose influence gets ever larger because of their collective power, not necessarily because of their dedication or ability to improving health care. As ProPublica put it,

Rosemary Gibson,
an author and senior adviser to The Hastings Center, a research group dedicated
to bioethics in the public interest, said she wasn’t surprised at Cassel’s
outside compensation. So much money permeates decision-making in Washington,
she said, that participants have become oblivious.

'The insiders
don’t see it,' Gibson said. 'It’s like a fish in water.'

Dr Cassel was previously the CEO of the American Board of Internal Medicine (ABIM). This non-profit organization also has a very substantial influence on health care. Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc. Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress.

Thus the content of the ABIM examinations and sponsored activities can influence physicians' thinking and decision making. How the ABIM under Dr Cassel's leadership dealt with conflicts of interest affecting those who write examinations, provide content, and lead the organization is unclear.

Furthermore, it seems possible that Dr Cassel had a conflict of interest generated by her work for Premier Inc while she was still CEO of ABIM. However, before Premier Inc made its initial public offering, information about its management and governance was scarce. Whether Dr Cassel was on the board of a precursor to the publicly traded Premier Inc is not easy to ascertain. Maybe the current ABIM leadership needs to consider whether Dr Cassel had a conflict involving Premier Inc or its precursor while she was CEO of ABIM, and how that conflict could have affected the direction of ABIM at the time.

How Would Dr Cassel Respond to Criticisms of Premier Inc and How Would that Reflect on the ABIM and the NQF?

Premier Inc is a hospital group purchasing organizations (GPOs). GPOs, particularly including Premier Inc, have been criticized for anti-competitive practices that distort the market in health care drugs and devices, for accepting the ethical equivalent of kickbacks, and particularly for generating drug shortages. For example, an opinion piece in the Baltimore Sun claimed,

The main reason is that most of these drugs are purchased through a
handful of supply chain middlemen called hospital group purchasing
organizations, or GPOs, whose anti competitive practices and self-dealing
have been documented in Senate antitrust hearings, media reports,
government investigations and lawsuits. These buyers' monopolies
purchase upward of $300 billion in drugs, devices and supplies annually
for about 5,000 private acute care hospitals, including virtually every
one in Maryland. Five giants account for roughly 90 percent of all such
purchases. [Apparently including Premier Inc - Ed]

Under a 'pay-to-play' arrangement, vendors compete not
on the basis of who can supply the best product at the best price but on
who can pay the biggest fees to these cartels. In return, they receive
exclusive contracts. This artificially constrained supply chain is why
many drug manufacturers have fled the marketplace, leaving just one or
two to produce many drugs. In turn, hospitals receive incentives based
on their compliance with contracts the GPOs award to favored suppliers.

In
1987, Congress enacted the Medicare anti-kickback 'safe harbor,' which
exempted GPOs from criminal penalties for accepting payments from
suppliers — payments that in virtually every other industry would be
considered unlawful kickbacks.

The GPOs trade organization vigorously contested this argument, of course.

But the awkward fact is that Dr Cassel, as a board member of Premier Inc, can be seen as a steward of that corporation, and hence responsible for the its overall direction. Thus, Dr Cassel could easily find herself in the uncomfortable situation of having to defend and justify questionable behavior by Premier Inc while simultaneously wearing the hat of CEO of NQF. How that would play out is not obvious.

Summary

So now it appears that the problems with conflicts of interest at the NQF affect not only its standard setting committees, board of trustees, and organizational funding. They also affect its CEO.

Dr Joe Collier said, "people who have conflicts of interest often find
giving clear advice (or opinions) particularly difficult." [Collier J.
The price of independence. Br Med J 2006; 332: 1447-9. Link here.] To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.

We previously suggested:that NQF leaders might also consider:
- further strengthening their conflict of interest policy for standard
setting committees, particularly by minimizing the number of committee
members with conflicts, and banning individuals with conflicts from
chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
- increasing transparency about conflicts of interest, particularly by
making disclosures for all projects available without complex web
searching
- decreasing institutional conflicts of interest by refusing funding
from health care corporations whose revenues might be affected by the
content of standards and guidelines, and reducing conflicts affecting
NQF board members and executives

I would now add that in my humble opinion, the NQF ought to immediately fully disclose any other conflicts that might exist affecting its committees, staff, board of trustees, or funding, and then begin a progressive but ultimately complete phase out of all significant conflicts affecting these areas.

The Phoenix-based health system did not immediately know what triggered the computer troubles that started just before 10 a.m. PST. An official described the computer troubles as a rolling outage of computer systems at hospitals and other health care facilities in Phoenix, Colorado and Nevada.

"Not knowing" means that you are not in control of your life-critical information systems; rather, they are in control of you.

By late Wednesday, a spokesman said, technicians had identified the problem and were fixing it. They expect to investigate the root cause of the problem Thursday.

It took from 10 AM to "late Wednesday" to identify a problem causing a mass outage. That should give anyone pause about dependency on fragile information systems in the hands of hospital IT departments (whose personnel undergo an ocean's less qualification-vetting than the medical personnel who depend on their work product) for one's medical care.

Banner Health, the Phoenix area's largest health care system, activated "downtime procedures" that included using paper-based systems to track medications and other care provided to patients, officials said.

Banner's emergency departments still provided care to patients and accepted new patients.

Some non-emergency surgeries and appointments were delayed because of the computer troubles.

"There have been some delays and inconveniences, but we are still providing care," said Bill Byron, Banner Health's senior vice president of public relations.

In other words, what they are saying is "we really don't need these systems, that cost hundreds of millions of dollars, to provide care with the same degree of safety as with our 'downtime procedures' (a.k.a. paper)" ... and that patient safety was not compromised by this mass outage.

Banner Health, which operates 24 hospitals and several primary-care offices and outpatient centers in more than a half-dozen states, was working to "reboot" the computer systems Wednesday evening through a series of sequential fixes, Byron said.

In the meantime, Banner officials were able to retrieve computer-based records that detailed patients' medical histories, including any medications, laboratory results and procedures that were previously performed.

Officials? What about line clinicians? And when did this capability start if the systems needed to be "rebooted?"

Information from those paper charts will be keyed into the patients' computer-based health records after the problem is fixed.

Sure, and nothing will be lost that could adversely affect patients in the future....

Banner Health has been among the most advanced health systems in the nation in converting to computer-based health records.

Banner Estrella Medical Center was among the first hospitals to open as an "all-digital" facility in the past decade. Banner's other hospitals have largely completed the final stages of installing computerized record-keeping in areas such as physician order and entry and electronic documentation.

If they are the most advanced, what does this event say about those less advanced?

Arizona law does not require hospitals to notify state health regulators in the event of such a widespread outage.

However, some hospitals have internal policies requiring that they notify health accrediting organizations or federal regulatory agencies, such as the Centers for Medicare and Medicaid Services, an Arizona Department of Health Services spokeswoman said.

Tuesday, February 18, 2014

I would bet that most people in the US still think our health care system is highly regulated. Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted. Of course, some people still think that the US has, or had until recently, the best health care system in the world (look here).

Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere. For example, after the chemical spill threatened water supplies in the capitol of West Virginia, the Dallas News reviewed Texas Governor Rick Perry's consistent attacks on government regulation.

'American business in general, and American agriculture specifically,
have had enough of bureaucracy at both the federal and state levels,
but especially bureaucracy out of Washington,' Perry said at a
congressional hearing. 'The men and women who feed and clothe this
nation are suffocating under the weight of mounting federal
regulations.'

That was back in 1993, when Perry was Texas’
agriculture commissioner. Now Texas’ longest-serving governor, Perry has
remained steadfast in his opposition to government regulations.

Some who take such a neoliberal stance may say the health care system is over-regulated, and thus is inefficient and not innovative, leading to our high costs and poor access.

However, an amazing case out of Governor Perry's Texas that was made public last year, and I regret I just heard about recently, suggests how little health care may be regulated, and how unregulated health care, whether or not it is efficient, may be deadly.

As reported in the Dallas News, July, 2013, in the last few years there seems to have been an epidemic of quality problems in a number of seemingly unrelated small rural Texas hospitals. The report focused first on one hospital,

Renaissance Hospital Terrell

After for-profit hospital corporation Renaissance Healthcare declared bankruptcy in 2008 (look here), it sold its hospital in Terrell, Texas to RH Terrell Management LLC owned by one Dr Tariq Mahmood. Almost immediately, however, there was trouble. First Edwina Henry, the quality director, spied a doctor making questionable entries in patients' charts:

from her office, she had a clear view of doctors’ foot traffic through the medical records department.

When
she saw [Dr Tariq] Mahmood jotting in patient charts, she knew he wasn’t seeing
patients. Mahmood himself had not been credentialed to treat patients — a
process in which management vets backgrounds and competencies of
doctors. Part of Henry’s job was tracking such evaluations. She also
knew it was a breach of privacy laws to review patients’ medical
records.

'I immediately questioned some of the clerks and
[insurance billing] coders,' she said. They were deeply concerned,
saying he was altering the patients’ records to help boost
reimbursements for insurance claims, Henry said.

When Ms Henry complained, things did not go well,

Henry made her confidential call to the bankruptcy court in early
November 2008, alleging potential fraud and threats to patient care that
were eluding government notice [Ed - note that the hospital was going through bankruptcy proceedings and had just been acquired by a new owner]. The court forwarded her complaint to
the U.S. Justice Department, the Texas attorney general’s office and the
state health department, officials confirmed.

Later that month,
the state health department sent an inspector to the hospital. However,
the visit was brief, Henry said, and the inspector didn’t interview her
or seek her help in obtaining records.

Williams, the health department spokeswoman, told The News her agency’s records show the inspector was unable to substantiate violations at the time.

Henry was terminated from Renaissance as part of a 'restructuring'....

Then the hospital was cited for turning patients away from the emergency department,

At Renaissance, two women in labor, one bleeding, were refused
treatment. The inspection reports don’t reveal whether the women
suffered complications because of the delays.

A Renaissance
employee told one of the women that if she 'could stand there and have a
conversation with them then (she) wasn’t about to have a baby,' reports
say.

Then there were problems with infection control,

At Renaissance, no supervision over infection control could be found.
For three months in the summer of 2010, no one was in charge of tracking
infectious diseases or preventing their spread.

The next year, the problem was blood transfusions

Inspectors returned to Renaissance in September 2011 to investigate a
botched blood transfusion procedure. They found that a registered nurse
had not supervised the patient’s care. In another case, an inspector
witnessed an unsupervised vocational nurse administering blood to a
patient, despite no evidence that she was competent to do so — another
violation.

In 2012,

During the summer, the Texas secretary of state had revoked Renaissance’s business charter for failure to pay franchise taxes.

That office didn’t share the information with the health department; it isn’t required to do so.

In
September, state health regulators notified Renaissance that they were
proposing a $35,050 fine for 13 violations, including the nursing
supervision failures, dating as far back as 2010.

Williams, the
health department spokeswoman, could not explain why the fine process
took nearly two years since the first violation.

Finally, in 2013, patients started to die,

In January of this year, when state inspectors returned to Renaissance, they found nursing supervision failures yet again.

This
time, the failures had led to three deaths: All ER patients. All with
severe breathing difficulties. All receiving little to no intervention
as their conditions worsened.

In particular,

[Eve] McCallum sought her own care after complaining of shortness of breath during a family dinner.

McCallum
had chronic obstructive pulmonary disease. When she was admitted,
nurses were ordered to monitor her vital signs and oxygen levels. Her
breathing soon improved, said her niece, Lou Ann Sims.

'We were fully expecting to pick her up the next morning,' Sims said.

Instead,
they watched helplessly as her condition deteriorated. On Christmas
Day, a physician explained to McCallum’s family that she had to be
transferred to the intensive care unit.

Later, Sims witnessed a
scene she can’t let go of: Her aunt lay connected to a ventilator while a
nurse stood smoking a cigarette just outside the door. The nurse had
propped open the door with an IV pole.

The family immediately
sought to have McCallum transferred to another hospital. But hospital
officials told them 'this would be a lateral move and was not allowed,'
according to a transcript of an interview the family later conducted
with state officials.

McCallum died two days later.

Inspectors
wrote that a licensed vocational nurse had been left in charge of her
treatment, without a registered nurse’s oversight. There was no evidence
an RN had assessed her condition on admission or was watching over her
in the ICU.

They could find no doctor orders to place her on
oxygen, no order for medications administered to her, 'nor evidence of
communication with the M.D.'

Suspecting more than just care
breakdowns at Renaissance, McCallum’s family reported her death to the
Texas attorney general’s fraud-control unit.

So partially in response to this egregious case,

By February, the state health department had moved to revoke
Renaissance’s operating license, and CMS had ordered its federal funding
terminated — only the ninth time nationally in the last three years CMS
had taken such a step.

Even those steps could not shut down the hospital, but city officials took that last step due to the failure to pay taxes.

Other Hospitals

Dallas News reporter Miles Moffeit found several other cases of severe problems at small hospitals owned by Dr Mahmood, with at least one patient death apparently resulting, .

Shelby Regional Medical Center

This hospital was owned by Tenet Healthcare, but was sold to another of Dr Mahmood's companies, Shelby Medical Holdings, in 2007 (look here).

In 2009, this hospital was also cited for providing insufficient treatment in the emergency department.

In 2012, things were really falling apart,

In October 2012, inspectors were at Shelby chronicling dirty, clogged
air-conditioners and failures to prevent ceiling plaster 'from falling
into the patient food service line and contaminating food.' Those
problems put patients’ safety in 'immediate jeopardy,' they wrote.

As
inspectors roamed Shelby’s halls in December, the power suddenly went
out in four buildings, though not in the main hospital facility itself.
The electric bill hadn’t been paid. They found other debts stacking up,
too — as much as $190,442 owed to as many as 79 service providers.

Signs
of neglect were everywhere. Only three of 20 patient rooms inspected
were 'fully functional for patient care,' they wrote. They found holes
in walls, dirty and tattered curtains, and patients complaining of heat
pouring from the faulty A/C system.

Finally, in 2013, another patient died,

On Wednesday, CMS cut off federal funding to ... Shelby Regional
Medical Center in Center in East Texas after regulators said a patient
rushed there by ambulance never received treatment from a doctor.

The ER physician wouldn’t leave his 'sleep room,' the inspection report said, resulting in the patient’s death. Regulators also cited the hospital for failing to vet backgrounds of doctors and nurses.

Apparently soon thereafter Dr Mahmood shut the hospital down due to "legal issues that ... [he] is facing," per the Shelby Light and Champion.

Lake Whitney Medical Center

Dr Mahmood apparently purchased this hospital from a struggling local hospital authority in 2007.

In 2009, it was cited for inadequate care in the emergency department,

At Lake Whitney, a nurse acknowledged to inspectors that she had
shredded records of a patient who was denied care following a fall,
according to a report. The 'patient wasn’t going to pay anyway,' the
nurse was quoted as saying in the document.

In 2010, there was evidence of major infrastructure problems,

At Lake Whitney, patients were served food on rusty 'over-the-bed tables
that were a source of possible infections for open wounds.' Bulging
ceiling tiles exposed pipes. Pavement outside a main hospital door was 'cracked and unlevel,' putting patients at risk of injury.

As Dr Mahmood's legal troubles mounted, the hospital was sold to Frontier Hospitals Inc (look here).

Cozby-Germany Hospital

I have been unable to discover when Dr Mahmood purchased this hospital.

In 2010, it became apparent that the hospital was not properly licensed,

'The administrator reported the new owner had not notified (CMS) … and
has not applied for hospital licensure with the state licensing agency,'
a report said. [The owner] ... also was found to have appointed his own
employees to the hospital’s governing board of directors, instead of
independent outsiders.

And there were more severe problems with credentialing,

At Cozby-Germany hospital, hospital inspectors discovered that the
chief of staff and another doctor had expired medical licenses. There
were no 'functional' nurse and doctor credentialing processes, and
clinical policies had not been updated since 2008, they said. The
hospital pledged reforms.

But in May 2011, records show, Cozby hired one of Texas’ most notorious doctors, Rolando Arafiles.

At
the time, Arafiles had been placed on probation by the medical board
for allegations of harming nine patients, overbilling and improper
coding at a Winkler, Texas, facility, according the board. He also was
disciplined for intimidating the Winkler nurses who blew the whistle on
his practices.

In November, Arafiles would be convicted of two felonies linked to the retaliation and would surrender his license.

In 2013, two local doctors purchased the hospital.

The Vanishing Owner

What made this series of cases all the more amazing is that it was really one interlinked case. All these hospitals, plus a few more, had the same owner. Yet no one, especially no one in state or federal government knew that until 2013 when the facts were uncovered by Mr Moffeit.

[Dr Tariq] Mahmood, a Pakistan-trained doctor, obtained his Texas medical
license in 1978. Since 2008, he has practiced medicine only at his
Central Texas Hospital in Cameron, south of Waco, records with the Texas
Medical Board show. Older documentation is not available.

Over
the last two decades, he has purchased at least six hospital companies
and two home-health care agencies, according to filings with the Texas
secretary of state. He also has invested his money outside health care,
acquiring the historic Hotel Lawrence in downtown Dallas, property
records show.

In addition to Renaissance, Shelby and Central Texas
Hospital, Mahmood owns the Lake Whitney Medical Center in Whitney and
Cozby-Germany Hospital in Grand Saline. He sold Community General
Hospital in Dilley around the time of his arrest in April.

The
hospitals have no common corporate identity and little or no website
presence, making it difficult for anyone to know they are owned by
Mahmood or are part of a chain.

However, much bout Dr Mahmood was mysterious, and the deliberate cultivation of mystery might have slowed the response to this case.

Mahmood is rarely seen in the communities where his hospitals are
located, say business associates and city officials. Sometimes they
catch a glimpse of him passing by in a chauffeur-driven car.

'He’s
almost impossible to track down' to discuss business matters, said Tom
Elliott, a director for a nonprofit company that owns the hospital
building in Grand Saline. 'He lets his people do the talking.'

Mahmood
is a mystery to many of his own employees. He works almost entirely
behind the scenes, they say, focusing largely on the business side of
his operations. He often is traveling or spending time at his
10,000-square-foot gated estate in Cedar Hill, they say.

'We see
him maybe once a year,' said one of his hospital physicians. 'The
employees say he doesn’t like confrontation. I say he just doesn’t like
to communicate. He seems to live in a different world.'

Aftermath

At some point, the shadowy Dr Mahmood may have to answer for all this, at least to some extent,

In April, federal authorities charged the 62-year-old Cedar Hill
resident with defrauding Medicare and Medicaid programs through $1.1
million in false billings.

Mahmood is accused of directing
employees at his Central Texas Hospital in Cameron to alter underlying
information in insurance claims from his other hospitals. 'In many
cases,' the indictment alleges, these were 'for patients he had never
seen.' Mahmood pleaded not guilty, and his attorney said he denies all
charges. He has declined repeated interview requests from The Dallas Morning News.

Note, however, that these are charges of financial fraud. They do not obviously have to do with poor quality care, risks to patients' safety, or the deaths of at least three patients as discussed above.

This case was so bad that even the current Governor of Texas, Rick Perry, a politician known for taking a small government, minimal regulation stance, at least said he was going to take some action, as reported again in the Dallas News,

The inspector general for the state Health
and Human Services Commission and one of the agencies it oversees, the
state health department, will conduct separate investigations, officials
said Friday.

And in February, 2014, the Dallas News reported that the chief financial officer of the Dr Mahmood's stealth hospital chain was also in hot water,

The top administrator of a chain of hospitals that collapsed under
the ownership of a North Texas physician faces charges that he defrauded
the federal government of nearly $800,000 in stimulus funds.

Joe
White of Cameron rose from maintenance man to head administrator and
chief financial officer over hospitals once owned by Dr. Tariq Mahmood.
Now he joins Mahmood in facing the possibility of prison time.

Like
Mahmood, who pleaded not guilty, White is accused of identify theft and
bilking the federal government of health care dollars. White has yet to
enter a plea.

Note that the CFO and apparently COO was not even a professional generic manager. He was a former maintenance man and operator of a Radio Shack store..

Dr Mahmood has not yet come to trial. Many questions about the case remain unanswered:
- Did Mahmood the only person besides his CFO cum maintenance man in charge of all this, or did he have other backers, cronies, associates?
- What happened to the rigorous state investigation promised by Rick Perry?
- Given that what went on harmed patients, and hence was not just financial manipulation, are there any civil lawsuits pending? Are there any other criminal investigations?\

Furthermore, despite its egregious nature, this case was amazingly anechoic The only national recognition I could find was in Paul Levy's Not Running a Hospital blog. Seven months later, I could find nothing in the national media, nothing in medical and health care literature. Despite the amazingly poor quality of care in evidence, despite the fact that patients died, I could find no cries of outrage from those who proclaim to support quality health care or patient safety.

Summary

Dr Mahmood and his chief operating and financial officer collectively displayed leadership that was ill-informed (the COO/ CFO was a former maintenance man), incompetent (see the egregious health quality problems listed above), self-interested (note the size of Dr Mahmood's mansion versus how little was obviously spent on his hospitals), opaque and dishonest (note how Dr Mahmood's ownership of the hospitals was obscured), and allegedly criminal. This leadership persisted over at least eight years until it culminated in cases of apparently needless patient deaths.

The amazing case of the stealth for-profit hospital system run by Dr Mahmood, and how its combined problems failed for so long to get systemic regulatory notice hardly suggest that our health care system is heavily regulated, or that current regulation can be relied upon to reassure patients that all is well and that the system is safe.

In fact, in the case of Dr Mahmood, government regulators did not seem to even want to know too much about hospital ownership,

Top health regulators weren’t even aware Mahmood owned several hospitals until The News
sought information about them earlier this year. Regulatory agencies
aren’t set up to track problem hospital owners or hold them accountable.
Nor do they look for patterns of care breakdowns inside hospital
chains.

'We just don’t have that authority,' said David Wright,
deputy regional administrator for CMS. The federal agency oversees the
state health department’s inspections of federally funded hospitals. 'We
can only address problems in stand-alone facilities.'

Furthermore, it appears that modern regulators have decided to become hospital managers' and owners' best friends,

The process allows hospitals to avoid sanctions if they cooperate.
Hospitals submit “corrective action plans” to remedy failures. It can
take months for state regulators to bring penalties such as fines
against a facility. In the case of Renaissance, it took years.

'We
want to do what’s in the best interest of the patients, and our
regulatory philosophy is to get hospitals into compliance,' said Carrie
Williams, spokeswoman for the Texas Department of State Health Services. 'We’re not in the business of shutting down hospitals. We will give
them some leeway and work with them.'

Of
course, this minimalist, light touch regulatory methodology may have made some sense in an earlier era when nearly
all hospitals were small community not-for-profit organizations,
non-profit academic institutions, or were run by local governments. It
seems quaint, and hopelessly out of date in an era when most hospitals
are part of ever larger systems, now often owned for-profit corporations, and when hospital system CEOs who
are professional, and thus generic managers, not health care professionals, in an era of financialization and "maximizing shareholder value," that is, making short-term revenue the most important outcome.

Instead, the current minimalist regulatory system seems insufficient to prevent patients from dying of poor care allowed by poor leadership of health care organizations. Much of the content of this blog has been about bad health care leadership, i.e., leadership that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt. In my humble opinion, health care regulation ought to be sufficient to promote competent, caring, unconflicted, honest leadership that is accountable for putting patients' interests ahead of self-interest. Regulation needs to be more intense, and much smarter, geared to the reality of a health care system that is now largely
for-profit in an era when management dogma puts revenue ahead of all
other concerns.

Maybe the deaths of some patients in Dr Mahmood's Texas hospital will finally let the air out of the mindlessly anti-regulatory bubble, and start some discussion of intelligent regulation to improve patient safety.

However, that cannot happen if this case remains anechoic. I regret it took me so long to find it, but now I have done my part to start some echoes. But where are the media, where are the journal editors, and where are those who so loudly proclaim their interest in patient safety and health care quality?

In particular, there are several prominent organizations that claim to promote health care quality and patient safety. These organizations make these claims-

The Leapfrog Group is a voluntary program aimed at mobilizing employer
purchasing power to alert America’s health industry that big leaps in
health care safety, quality and customer value will be recognized and
rewarded.

Transforming our healthcare system to be safe, equitable, and of the
highest value will take time and the work of many, but the potential
rewards are great. The National Quality Forum (NQF) is a nonprofit,
nonpartisan, public service organization committed to this
transformation.

Our efforts focus on improving both the health of everyone in America
and their health care—how it's delivered, how it's paid for, and how
well it does for patients and their families.

These organizations should the ones to start the conversation about improving rather than forever shrinking regulation. I have not heard anything from them about the deadly hospitals of Dr Mahmood. Are they listening now? Will we ever hear from them? Time will tell....

Note: the entire Dallas News series on the Mahmood hospitals can be found here.

Thursday, February 13, 2014

Radio station News 88.9 KNPR, the NPR affiliate in Las Vegas did a segment today on the following news story. The station's Senior Producer had invited me to participate via phone regarding patient privacy issues.

Dignity Health, the owner of St. Rose Dominican Hospitals, is facing a federal complaint alleging it violated patient privacy by using patient records as leverage in a contract dispute.According to a Monday announcement from the Nevada Health Services Coalition, Dignity Health used patient records to contact those with coalition member plans after agreements between the two agencies fell through in January, something it contends violates the Health Insurance Portability and Accountability Act, or HIPAA. The complaint was filed with the U.S. Department of Health and Human Services Office of Civil Rights.

The complaint contends St. Rose contacted former patients in an attempt to persuade them to take action with their health plans favorable to St. Rose. The complaint also said that St. Rose claimed their actions were simply to be “informative.”

“It’s our position that patient data collected in the course of medical treatment should not be used to lobby or gain leverage in contract negotiations,” said Christine Carafelli, executive director of the coalition.

The Nevada Health Services Coalition is a nonprofit entity that negotiates hospital contracts for discounted health care service rates for 19 member group organizations, totaling approximately 230,000 Nevada residents.

A spokesperson for St. Rose said they would issue a statement on Tuesday.

The segment has now completed. It was hosted by Dave Becker of KNPR.

A representative of the Health Services Coalition (http://www.lvhsc.org/), a
local organization of union, casino and local government health funds
who bargain together for maximum
leverage, participated, as did a hospital VP.

The coalition is accusing the St. Rose hospital group (a division of
Dignity Health) of using patient records to contact patients to urge
them to lobby for the hospital in contract negotiations.

I was asked for an opinion on the acceptability of access to patient information in an organization's EHR systems (including PHI such as name, address and other contact information) for purposes of soliciting the patients to lobby the insurers on behalf of the healthcare organization for better terms.

My opinion was clear, which I summarize as follows:

1. Hospitals do not "own" patient data to use as they please. Is is not a simple business asset, like typewriters - or computers. Any belief that a hospital can treat patient records as such, to be used as they pleased, would reflect arrogance;

2. The HIPAA privacy rule and its exceptions (viewable at http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/, section under "Permitted Uses and Disclosures") would preclude the use of patient's private and protected information in an EHR for selective solicitation for lobbying on behalf of the hospital;

3. Who accessed the patient information, and exactly what they accessed, is not clear, and an electronic audit trail needs to be disclosed as to these issues;

5. The hospital could have accomplished such goals transparently, safely, and without access to private health information, by putting an ad on the radio (or newspaper etc.), or mailing a general newsletter such as I often receive from area hospitals, even hospitals where I was never a patient.

A hospital VP contributed soothing words that the hospital respects patient privacy, trusts its employees and doesn't wish this matter to become a stumbling block in negotiations. However, in my opinion the hospital violated the HIPAA privacy rules and potentially put patient privacy at risk.

No
amount of soothing, deflecting executive language and shifting of the
discussion can change that, and a full disclosure accounting would be
proper.

(I note the HIPAA privacy rules do not state "For informational purposes only. Use patient information however you want if you trust your employees and you think the risk is low..")

That is, assuming an audit trail of sufficient detail is recorded in their EHRs, assuming it is turned on, and assuming it can be trusted in light of the HHS OIG report of Dec. 2013 where many hospitals admitted EHR audit trails can be deleted or edited by a person with appropriate credentials. (See my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html).

A thought experiment demonstrates just how far from propriety, in my opinion, this affair is:

If a hospital can use confidential information in this manner, to enlist patients as de facto lobbyists regarding an insurer, then why could not a hospital use other data - e.g., patients' disease burden, smoking status or even sexual orientation to ask them to lobby, say, a politician to gain some advantage, such as certificate-of-need approval for expansion, or anti-competitive legislation? Or, to ask patients to participate in political activities for/against some politician or group that might hold views or conduct activities favorable/unfavorable to the hospital's interests?

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